Top Menu

FDA sets new limits on use of immediate-release opioids

After years of criticism that they were not doing enough to fight the growing abuse of opioids, federal authorities are piling on new guidelines and warnings for the powerful painkillers. The FDA is the latest with box warnings about what it called the serious risks of misuse, abuse, addiction, overdose and death.

The agency said that because of the danger that patients can get addicted to drugs like oxycodone, hydrocodone and morphine, labels would make it clear that immediate-release versions should only be given for severe pain when nonaddictive drugs are not enough. The FDA will provide new cautions about dosing and "a warning not to abruptly stop treatment in a physically dependent patient." Immediate-release versions make up the vast majority of prescriptions for the painkillers.

The labels also will lay out the fact that there is a risk that the babies of women who take opioids during pregnancy will be born with what is called neonatal opioid withdrawal syndrome (NOWS). The condition can be "life-threatening" so it needs to first be recognized by doctors and then treated using certain protocols established by neonatal experts, FDA said.

FDA commissioner Robert Califf

"Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic," the FDA's new commissioner, Robert Califf, said in the announcement.

Califf in February, just ahead of his confirmation as FDA commissioner, said the FDA would undertake a sweeping re-examination of its policies on approving opioids. He also put forth an 8-point plan that he said would "focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief."

The FDA action on Tuesday followed by a week the voluntary guidelines from the Centers for Disease Control and Prevention (CDC) intended to rein in the overprescription of the highly addictive drugs by first-line providers such as primary care physicians and physician assistants. They recommend that for short-term pain, clinicians first try alternatives such as nonsteroidal anti-inflammatory drugs along with physical therapy. If they prescribe opioids, the CDC suggests first giving the minimum dose and to prescribe only three days' worth of pills, saying some patients can become addicted more quickly than might be expected.

The FDA has been criticized for years for approving new addictive painkillers based solely on their medical use and not taking into account how they might factor into a growing rate of addiction in the country. Abuse experts say rampant use of opioids has led to greater heroin use, which addicts often turn to because it is cheaper. It has also meant a growing rate of death from overdoses. According to CDC stats, the rate of drug overdose deaths from prescription opioids and heroin tripled between 2000 and 2014.

The addiction problem has become the focus of an expansive public policy debate with politicians, law enforcement officials and anti-addiction groups often blaming drugmakers for feeding the problem with aggressive marketing and federal agencies for not responding to it.

Califf, whose nomination was briefly held up by a senator who insisted the FDA change the way it approves opioids, responded with his 8-point plan. It includes having a panel of experts weigh in on any new opioid up for approval and its potential impact on the addition problems in the U.S.